Oncoplastic surgery training model

ABSTRACT

Described herein are anatomical models for medical training, surgical planning, or patient demonstration. The anatomical models include a replica of a target body part that may be altered, unfinished, or deformed so that an anatomical component may be attached thereto to complete the replica and provide visual training with respect to symmetry and other aspects of medical or surgical procedures. For example, the anatomical models may be altered, unfinished, or deformed to simulate a post-surgical deformity. Systems and methods including the anatomical models are also described herein.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 63/082,175 filed on Sep. 23, 2020, which is hereby incorporated byreference in its entirety.

FIELD

This application relates to anatomical models for medical training orpatient demonstration. The anatomical models include a replica of atarget body part, but may be physically altered in a manner thatsimulates a deformity so that an anatomical component may be attachedthereto to complete the replica and provide visual training with respectto symmetry and other aspects of medical or surgical procedures. Systemsand methods including the anatomical models are also described herein.

BACKGROUND

Every year, hundreds of thousands of women around the world arediagnosed with breast cancer. While breast conservation has increased innumbers, there are still many women who are treated with mastectomy(removal of the entire breast). Unfortunately, mastectomy often leaveswomen cosmetically deformed, which in turn dramatically impacts theirbody image and quality of life. In the United States, there are fewsurgeons trained in the art of breast reconstruction. Thus, there is alarge need to train additional surgeons to be able to provide breastreconstruction services. Although breast reconstruction has beenavailable since the 1980's, these procedures are still relatively rare,with studies indicating that roughly only 20% of women undergoingmastectomy have immediate breast reconstruction at the time the breastis surgically removed.

Additionally, over the past several decades, there has been an effort totry and offer breast conserving surgery to more women since roughly 60%of breast cancers are now found at an early stage using screeningmammography. For those women who are able to save their breast, studiesindicate there is a large proportion of women who suffer from poorsurgical outcomes after these procedures. In fact, more than 30% ofwomen who save their breast report a poor aesthetic outcome. Many ofthese women have more than one operation in an attempt to improvesurgical deformities that occur from removal of the tumor. Additionally,these deformities can be compounded by severe scarring secondary to theradiation therapy required in most cases when the breast is preserved.These poor cosmetic outcomes resulting after surgery of the breast, areoften difficult, if not impossible to correct and thus, many women areleft permanently scarred and deformed.

In both the case of mastectomy and breast conserving surgery, thepsychosocial impact on women relating to breast deformity may be quitesignificant. In the late 1980's a number of surgeons realized thisdifficult situation and began practicing new techniques known asoncoplastic surgery. These procedures are designed to take many factorsinto consideration when planning breast surgery, including the size,shape, and structure of the breast in its pre-operative form. Also, thesize, location, and type of tumor may be important to consider whendeciding how much volume should be removed from the breast. Thesefactors often determine the specific surgical procedure that will becompleted. The location of the surgical incisions is another key factorto be considered. However, although scarring is a concern of most women,several studies have shown that symmetry is the single most importantfactor to a patient's acceptance and happiness following breast surgery.

In general, the planning involved with breast surgery first involves acomplete analysis of the cancer using imaging and biopsy techniques todetermine the exact nature of the tumor within the affected breast.Various factors about the tumor such as the size (volume), the locationor quadrant within the breast, the distance from the nipple-areolarcomplex, the proximity to the axilla, etc., are determined. Next, thetype of procedure is considered, including a determination of whethermastectomy or breast conservation is the best option. The surgicalapproach and location of the incision(s) is determined and the decisionregarding the type of reconstruction is analyzed and discussed in greatdetail with the patient. Additionally, the unaffected breast isthoroughly analyzed as well to make sure it is free of cancer and todiscuss with the patient how she feels about the size, shape andappearance of her breasts. An extensive discussion regarding the risks,complications, and options is completed before the surgical plan isfinalized. However, surgical planning can be a very difficult taskwithout any visual tools to assist the surgeon or the patient inobtaining a clear understanding of the patient's desire for theaesthetic outcome and overall appearance of the breast(s). For decadesthese difficult decisions and conversations have taken place in a vacuumof information for both the surgeon and the patient. Surgical planningis often quite challenging without the availability of athree-dimensional model or simulator for the surgeon to work with inorder to visualize the most appropriate and optimal surgical approach.

Accordingly, systems and methods for improving oncoplastic (as well asother) surgical training, planning, and techniques would be useful. Morespecifically, systems and methods for improving a surgeon's ability toprovide better cosmetic outcomes of breast surgery, for example, bymaintaining breast symmetry, would be beneficial.

SUMMARY

Described herein are anatomical models for medical training, surgicalplanning, or patient demonstration. The anatomical models include areplica of a target body part, but may be altered, unfinished, ordeformed in a manner that replicates a deformity, e.g., a post-surgicaldeformity, so that an anatomical component may be attached thereto tocomplete or reform the replica and provide visual training with respectto symmetry and other aspects of medical or surgical procedures. Systemsand methods including the anatomical models are also described herein.

More specifically, the anatomical models may be used to assist intraining surgeons in the skill and art of breast reconstruction, breastconservation, and breast restructuring. In addition to breasts, themodels may represent other body parts that require an aesthetic planningaspect to the procedure, for example, those procedures on the face ornose, or other procedures where symmetry is desirable. The models may beused to visually train surgeons in several aspects of pre-surgicalplanning. For example, the models may help train surgeons visualize theoptimal place to make an incision, where volume may be removed, wheretissue rearrangements may be able to assist with achieving symmetry,etc. Furthermore, the surgeons may use the models to practice varioustechniques manually, which helps to imprint these surgical principles intheir mind as well as demonstrate to patients various procedures thatcould be done to achieve certain outcomes.

In general, the anatomical models described herein comprise athree-dimensional replica of a human body part. The three-dimensionalreplica may include a mounting area in an altered, unfinished, ordeformed portion thereof, where the replica may be configured forcompletion or reforming by attaching a simulated anatomical component ofthe body part to the mounting area. The body part may be a female torsoand the simulated anatomical component, a breast. The anatomical modelsmay also include other body parts and simulated anatomical components.In some variations, the mounting area may be configured for removableattachment of the anatomical component. In other variations, thesimulated anatomical component may be configured for sculpting onto themounting area. In one variation, the anatomical model is configured forbreast surgery training and demonstration. Here, the three-dimensionalreplica may include a female torso having an altered or unfinishedportion simulating the post-surgical changes seen after mastectomy,where the replica may be configured for completion by sculpting asimulated breast onto the mounting area.

Systems for modeling a body part are also described herein. The systemsgenerally include an adjustable base and a three-dimensional replica ofthe body part for coupling to the adjustable base, where thethree-dimensional replica may include a mounting area in an altered,unfinished, or deformed area of the three-dimensional replica. One ormore materials may be included in the systems and be configured tosimulate an anatomical component of the body part. The systems mayfurther include a mechanism for altering the angle of the adjustablebase with respect to a working surface, for example, a hinge, ratchetingmechanism, or telescoping tube. The body part may be a female torso andthe simulated anatomical component, a breast. The anatomical models mayalso include other body parts and simulated anatomical components.

Further described herein are methods related to using the anatomicalmodels for training and patient demonstration. In general, the methodsmay include creating a three-dimensional replica of a body part, wherethe three-dimensional replica includes a mounting area in an altered,unfinished, or deformed portion thereof. The replica may be completed orreformed by attaching a first simulated anatomical component of the bodypart to the mounting area. The simulated anatomical component may be abreast, but other anatomical components may be employed. In someinstances, attachment of the first simulated anatomical component may beachieved by sculpting the component onto the mounting area. In otherinstances, the method may include interchanging the first simulatedanatomical component with a second simulated anatomical component havinga different size, a different shape, or a combination thereof.

The anatomical models may be used during breast surgery planning, forvisual training of anatomical assessment, e.g., assessment for symmetry,for visual training relating placement of surgical incisions,determining the surgical approach for tumor removal, reconstruction, orrestructuring of the breast, or for visual training relating to breastimplant placement. The anatomical models may also be used for patientdemonstration, as a tool to illustrate various procedures to achievecertain outcomes.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D depict exemplary simulated anatomical components attached toan anatomical model. In FIGS. 1A and 1B, the simulated anatomicalcomponent (a breast) is removably attached to a mounting area of theanatomical model; and in FIGS. 1C and 1D, the simulated anatomicalcomponent is sculpted onto the mounting area of the anatomical model.

FIGS. 2A-2C depict an exemplary breast mold and elements for attaching amolded breast to an anatomical model.

FIGS. 3A-3E depict an exemplary adjustable base for attachment of ananatomical model.

FIG. 4 depicts another exemplary adjustable base of the system.

FIGS. 5A and 5B depict an exemplary system including an anatomicalmodel. FIG. 5A is a front view of the system; and FIG. 5B is aperspective view of the system.

FIGS. 6A and 6B depict an exemplary mechanism including a telescopingtube for adjusting the viewing angle of an anatomical model. FIGS. 6C-6Fshow how adjustment of the telescoping tube varies the viewing angle ofthe anatomical model with respect to a working surface.

FIGS. 7A-7D depict another exemplary mechanism for adjusting the viewingangle of an anatomical model.

FIGS. 8A-8D depict various deformities as a result of breast surgery.

FIGS. 9A-9B depict a side, cross-sectional view of an exemplary coverfor an anatomical model.

FIG. 10 depicts an exemplary cover representative of the anatomy for afemale torso.

FIG. 11A depicts an exemplary cover of a female torso including amounting area in an unfinished state. FIG. 11B depicts the cover of FIG.11A in a finished state.

FIGS. 12A-12D illustrate how an exemplary female torso may be used as ateaching tool for breast surgery.

DETAILED DESCRIPTION

Described herein are anatomical models for medical training, surgicalplanning, or patient demonstration. As previously stated, the anatomicalmodels may include a replica of a target body part, but may be altered,unfinished, or deformed (e.g., in a manner that simulates post-operativesurgical changes), and so that an anatomical component may be attachedthereto to complete or reform the replica and provide visual trainingwith respect to symmetry and other aspects of medical or surgicalprocedures (e.g., placement of surgical incisions, various anatomicalplanes, etc.). The anatomical models may be useful in the field ofbreast surgery. After mastectomy or breast conserving surgery, breastdeformities may be quite significant. FIGS. 8A-8D illustrate the variousdeformities that may result from mastectomy (FIG. 8A) and breastconserving surgeries (FIGS. 8B-8D). The anatomical models describedherein may be useful in training surgeons so that cosmetic outcomes maybe improved, as well as functioning as a demonstrative and educationaltool to prepare patients on what to expect from certain breastprocedures.

Systems and methods including the anatomical models are also describedherein. The systems generally include an anatomical model, an adjustablebase to which the anatomical model is attached, and one or moresimulated anatomical components for removable attachment to theanatomical model, or one or more materials that may be used to create asimulated anatomical component of the body part. Furthermore, thesystems may be configured for easy mounting to a variety of workingsurfaces and adjustment to various viewing angles. The systems may beportable, and thus in some instances may be sized to be packable.

Anatomical Models and Simulated Anatomical Components

In some variations, the anatomical models described herein comprise athree-dimensional replica of a human body part. The three-dimensionalreplica may be representative of various human body parts, includingwithout limitation, a female or male torso, a face, a head, feet, hands,etc. Replicas of other body parts are also contemplated. In onevariation, the anatomical model may be a three-dimensional replica of afemale torso.

The replicas may include a mounting area in an altered, unfinished ordeformed portion thereof, where the replica may be configured forcompletion or reforming by attaching a simulated anatomical component ofthe body part to the mounting area. The simulated anatomical componentmay represent a human anatomical component, and will typically depend onthe body part for which the replica is being made. For example, thesimulated anatomical component may be a breast, an ear, a nose, a jaw,fingers, toes, etc. Other simulated anatomical components may be used.

In some variations, the mounting area may be configured for removableattachment of the simulated anatomical component so that differentsimulated anatomical components, for example, components having adifferent size or shape, may be interchanged. Here, the simulatedanatomical component may be provided as a pre-formed part and thenattached to the anatomical model, or shaped and/or sized by a user andthen attached to the model. A base plate may be used as an intermediateelement in these variations to aid in attachment of the simulatedanatomical component to the model. For example, the simulated anatomicalcomponent may be coupled to a base plate and the base plate attached tothe mounting area of the anatomical model. Attachment mechanisms suchas, but not limited to, Velcro® fasteners, hooks, snaps, magnets, andslot-in type attachments may also be employed to attach the base plateto the mounting area.

In other variations, the simulated anatomical component may beconfigured for sculpting onto the mounting area. The simulatedanatomical component may first be attached to the mounting area of thebody part replica and then shaped, sized, and/or positioned to completean unfinished replica, or to fix or reform a deformity in the replica.For example, the simulated anatomical component may be used to completean unfinished replica made to represent a mastectomy patient. In anothervariation, the simulated anatomical component may be used to reform adeformity in a replica made to represent a divot in a breast due to abreast biopsy.

The anatomical models and simulated anatomic components may be made fromvarious materials. In one variation, the anatomical models and simulatedanatomic components may be made from a thermoplastic polymer. Exemplarythermoplastic polymers include without limitation, acrylic,acrylonitrile butadiene styrene (ABS), polyamide, polycarbonate,polyester, polyethylene, polypropylene, polystyrene, polyurethane, orderivatives or combinations thereof. Other materials such as siliconesand rubbers may also be used. When the simulated anatomical component issculpted onto the mounting area, the component may be made from aclay-based or other malleable material. The clay-based material may be apolymer clay (modelling clay), a water-based clay, or an oil-based clay.

The anatomical models may include a three-dimensional replica of anybody part or any simulated anatomical component suitable for medicaltraining, surgical planning, or patient demonstration. In one variation,the three-dimensional replica may be a human female torso and thesimulated anatomical component may be a breast. For example, referringto FIGS. 1A-1D, an anatomical model (100) that is a three-dimensionalreplica of a human female torso (102) is shown. In FIG. 1A, torso (102)resembles a post-operative mastectomy deformity and has an unfinishedside (101) including a mounting area (104) for attachment of a simulatedbreast (106). FIG. 1A shows the simulated breast (106) unattached to themounting area (104), and FIG. 1B shows the simulated breast (106)attached to the mounting area (104). The simulated breast (106) in FIGS.1A and 1B may be removably attached to the mounting area (104) of torso(102). In another variation, as shown in FIGS. 1C and 1D, attachment ofthe simulated breast (106) may be achieved by sculpting the breastdirectly onto the mounting area (104). Similar to FIG. 1A, FIG. 1Cprovides a torso (102) resembling a post-operative mastectomy deformityhaving an unfinished side (101) that includes a mounting area (104). Asimulated breast (106) may be sculpted on the mounting area (104) usingclay to appear symmetrical with the other side, as shown in FIG. 1D. Useof these anatomical models may be beneficial for medical training,surgical planning and patient education, as previously stated.

In some variations, as shown in FIGS. 2A and 2B, a simulated breast(200) may be formed from a material (e.g., modelling clay), using a mold(202). The simulated breast (200) may directly adhere to a base plate(204), which may then be coupled to a mounting area. This simulatedbreast may then be altered in a manner that would resemble potentialsurgical outcomes. FIG. 2A provides a side view of the mold (202),simulated breast (200), and base plate (204), while FIG. 2B provides across-sectional view of those components taken along line A-A in FIG.2A. Alternatively, as shown in FIG. 2C, a mold (not shown) may create ahole or depression (206) in simulated breast (200) that mates with acorresponding structure (e.g., a peg) (not shown) fixed to a base plate.

In another variation, the three-dimensional replica may be a human faceand the simulated anatomical component may be at least a portion of anose, eye socket, or mouth. In yet another variation, thethree-dimensional replica may be a human head and the simulatedanatomical component, an ear. In further variations, thethree-dimensional replica may be human hands or feet, and the simulatedanatomical components may be one or more fingers or toes, respectively.

The dimensions of the anatomical models will generally vary based on thebody part being modelled as well as the particular size and/or shape ofthe body parts of the patient from whom the model is generated. In somevariations, when the anatomical model comprises a human female torso,the length of the torso may range from about 8.0 inches (20.3 cm) toabout 16 inches (40.6 cm), including all values and sub-ranges inbetween. For example, the length of the torso may be about 8.0 inches(20.3 cm), about 9.0 inches (22.9 cm), about 10 inches (25.4 cm), about11 inches (28.0 cm), about 12 inches (30.5 cm), about 13 inches (33.0cm), about 14 inches (35.6 cm), about 15 inches (38.1 cm), or about 16inches (40.6 cm). The width of the torso may range from about 10 inches(25.4 cm) to about 20 inches (50.8 cm), including all values andsub-ranges in between. For example, the width of the torso may be about10 inches (25.4 cm), about 11 inches (28.0 cm), about 12 inches (30.5cm), about 13 inches (33.0 cm), about 14 inches (35.6 cm), about 15inches (38.1 cm), about 16 inches (40.6 cm), about 17 inches (43.2 cm),about 18 inches (45.7 cm), about 19 inches (48.3 cm), or about 20 inches(50.8 cm). The height of the torso may range from about 5.0 inches (12.7cm) to about 10.0 inches (25.4 cm), including all values and sub-rangesin between. For example, the height of the torso may be about 5.0 inches(12.7 cm), about 6.0 inches (15.2 cm), about 7.0 inches (17.8 cm), about8.0 inches (20.3 cm), about 9.0 inches (22.9 cm), or about 10 inches(25.4 cm). In one variation, the human female torso model has a heightbetween about 5 inches (12.7 cm) to about 7.0 inches (17.8 cm). Inanother variation, the human female torso model has a length of about8.5 inches (21.6 cm), a width of about 11 inches (27.9 cm), and a heightof about 5.5 inches (14 cm).

The anatomical models may be used as a teaching tool for physicians andsurgeons by visually demonstrating a variety of different conditions andprocedures relating to breast augmentation, reconstruction, and/ortissue removal. The models may be useful when planning breast surgeriessuch as tumor removal with local tissue reconstruction, breastreduction, or breast augmentation or reconstruction. For example, themodels may help a surgeon visualize and understand the outcome of usinga round vs. other shaped implants in breast augmentation andreconstruction, as well as understand how to avoid and revise the mostcommon breast implant malposition and sizing complications. As ateaching tool for patients, the model may be used to demonstrate breastimplant complications, including but not limited to, malpositiondeformities, palpability, visibility, capsular contracture, over sizingand under sizing of breast implants, rotation of shaped implants, andthe different appearance of round and shaped breast implants. The modelsmay also incorporate anatomic tissue planes (e.g., muscular planes,fascial planes, etc.) in order to instruct surgeons on best practicesfor achieving optimal outcomes. These planes may be incorporated intovarious accessories (e.g., covers) that may be attached to the variousmodels to create different clinical scenarios or situations that may beencountered.

The anatomical models may first be created by generating a cast of aliving human or patient. The models may then be altered to simulatesurgical intervention (such as mastectomy) or to create a deformity. Insome variations, the anatomical models may simply provide a foundationfor demonstrating various surgical procedures.

Once the cast is generated, it may be produced in other ways. Forexample, the cast may be formed by 3D printing or by creating a moldfrom the cast and then re-casting the model using different materials.The materials are generally durable and lightweight, and may have asurface that allows various materials to stick to it such as clay.However, simulated body parts such as a breast may be created with anattachment mechanism so that there may be interchangeable sizes andshapes to work with, as previously stated. In some variations, themodels may be made by processes capable of mass production so thatclasses may be taught, not only for surgeons, but perhaps for artists,anatomists, etc. Additionally, the models may be used in conjunctionwith large workshops or they may be used as home study tools inconjunction with online teaching courses.

Bases

The anatomical models may be attached to a working surface using a base.Working surfaces may include, for example, a working bench, a table, acounter-top, or other solid surface. In some variations, the anatomicalmodels may be attached to a working surface using an integrated baseconfigured such that the torsos are attached to the base, and the baseis attached to a working surface. In other variations, the base maycomprise two parts, a bottom plate that may be fastened to the workingsurface, and a top plate that attaches to the anatomical model. The topplate generally includes attachment mechanisms for securing theanatomical model in place. These attachments may be used to interchangevarious models onto the top plate, and may include without limitation,screws, removable adhesive, Velcro® fasteners, magnets, hooks, and anyother suitable male-female type couplers. Any number of attachments maybe employed to secure the anatomical model to the base. For example,one, two, three, or four attachments may be used. In one variation, fourscrews are used to secure the anatomical model to the base.Additionally, the attachment mechanisms may be spaced in any suitablefashion upon the base.

The base may be made from various materials. Polymers such asthermoforming polymers or those used in injection molding may be used.Additionally, metals may be used. Exemplary polymer materials that maybe employed include without limitation, acrylic, acrylonitrile butadienestyrene (ABS), polyamide, polycarbonate, polyester, polyethylene,polypropylene, polystyrene, polyurethane, or derivatives or combinationsthereof. Examples of metal materials include, but are not limited to,aluminum, steel, and alloys thereof. In one variation, the base is madefrom polycarbonate. In other variations, the base is made from wood. Insome variations, polycarbonate sheets that are heated and then bent atone end are used to form the base. In yet further variations, the baseis made from sheet metal (e.g., aluminum sheets that are bent to formthe base).

The base may have various dimensions and be provided in various shapes.For example, the base may be shaped as a rectangle, square, triangle,circle, or an oval. When provided as a rectangle or square, the topplate of the base may have a length ranging from about 10 inches (25.4cm) to about 24 inches (70 cm), a width ranging from about 8.0 inches(20.3 cm) to about 20 inches (50.8 cm), and a height ranging from about4.0 inches (10.2 cm) to about 6.0 inches (15.2 cm). In one variation,the base is rectangular in shape and has a top plate with a length ofabout 11 inches (30 cm), a width of about 8.0 inches (20.3 cm), a heightof about 6.0 inches (15.2 cm), and a thickness of about 0.25 inches(0.64 cm). The bottom plate may also have the same shape and the same orsimilar dimensions as the top plate.

The top and bottom plates may be connected to one another by a hingethat pivots the top plate with respect to the bottom plate, and amechanism that allows the angle between the top and bottom plates to beadjusted by a user. The adjustment mechanism may modify the viewingangle of the anatomical model to that desired by the user. In onevariation, the angle between the top and bottom plates may be adjustedby a ratchet assembly, e.g., a ratcheting headrest. In a furthervariation, a telescoping tube with a removable pin may be coupled to thetop and bottom plates for adjusting the angle therebetween.

Referring to FIGS. 3A-3E, top and bottom plates of an exemplary base areshown. In FIG. 3E, a side view of a base (300) is shown having a topplate (302), a bottom plate (312), and a hinge (301) therebetween. InFIG. 3A, top plate (302) has four inserts (304) for receiving screwsthat removably secure the anatomical model to the base. Openings (306)are also provided for attachment of a first end of a mechanism (see,e.g., FIGS. 7A-7E) for adjusting the viewing angle of an anatomicalmodel. As shown in the cross-sectional view of FIG. 3B, a lip (308) atone end of top plate (302) forms a space (310) that allows the top plate(302) to be spaced from a bottom plate of the base (300). The height (H)of the lip (308) may be about 0.5 inches (1.30 cm), as shown in FIG. 3B.However, in general, the height of the lip may range from about 0.5inches (1.30 cm) to about 2.0 inches (5.10 cm), including all values andsub-ranges in between. For example, the height may be about 0.5 inches(1.30 cm), about 1.0 inch (2.54 cm), or about 1.5 inches (3.81 cm).Referring back to FIG. 3B, the width (W) of the lip (308) may be about1.5 inches (3.81 cm). However, in general, the width of the lip mayrange from about 0.5 inches (1.30 cm) to about 2.0 inches (5.10 cm),including all values and sub-ranges in between. For example, the widthof the lip may be about 0.5 inches (1.30 cm), about 1.0 inch (2.54 cm),or about 1.5 inches (3.81 cm).

In FIG. 3C, a bottom plate (312) is shown including openings (314) forattachment of a second end of a mechanism for adjusting the viewingangle of an anatomical model (see, e.g., FIGS. 7A-7E). As shown in thecross-sectional view of FIG. 3D, a second lip (316) at one end of bottomplate (312) forms a second space (318) to allow for a working surfacesuch as a tabletop to be inserted therein and clamped. The height (H) ofthe second lip (316) may range from about 0.5 inches (1.30 cm) to about4.0 inches (10.2 cm), including all values and sub-ranges in between.For example, the height of the second lip may be about 0.5 inches (1.30cm), about 1.0 inch (2.54 cm), about 2.0 inches (5.10 cm), about 3.0inches (7.6 cm), or about 4.0 inches (10.2 cm). In one variation, theheight of the second lip may be about 3.0 inches (7.6 cm), and the width(W) of the second lip (316) may be about 2.5 inches (6.4 cm).

In another variation, as shown in FIG. 4, another exemplary base (400)is shown. Base (400) includes a top plate (402) and a bottom plate(404). Bottom plate (404) includes a channel (406) that may be used toadjust the angle of top plate (402), which in turn may adjust theviewing angle of an anatomical component. Here the gap or space providedby channel (406) may allow the angle of the top plate to be adjusted(e.g., to create a smaller or larger angle with the bottom plate (404)at its connection with the bottom plate (404)). Base (400) may alsoinclude a clamp (408) into which an end of a working surface may beplaced, and through which a screw (410) may be tightened to secure theworking surface within the clamp (408). The top and bottom plates may bethermoformed plastic sheets, and the channel may be an extruded aluminumchannel.

The base may be made by various processes. In one variation, the basemay be manufactured from a polycarbonate sheet. The sheet may be cut tosize and then the corners rounded. Holes may be drilled and heat-setthreaded inserts placed therein in desired positions in the base. Next,the sheet may be formed using a hot wire and bending jig. Othermanufacturing techniques such as thermoforming, injection molding, orsheet metal forming may also be employed.

In some variations, the anatomical model comprises a cover that may beremovably secured to at least a portion of the anatomical model. Thecover may include a mounting area in an altered, unfinished, or deformedstate, which may be configured for completion or reforming by attachinga simulated anatomical component of a body part to the mounting area.The simulated anatomical component may represent a human anatomicalcomponent, and will typically depend on the body part for which thereplica is being made. For example, the simulated anatomical componentmay be a breast, an ear, a nose, a jaw, fingers, toes, etc. Othersimulated anatomical components may be used.

The cover may take various forms. For example, the cover may be a singlelayer of material or may comprise multiple layers of material. Thesingle or multiple material layers may be made to represent the varioustissue layers, for example, of a human body part or anatomical area. Thelayers may represent, skin, subcutaneous fat, breast tissue, muscle,etc. In one variation, the cover may be made from one or morethermoplastic polymers. Exemplary thermoplastic polymers include withoutlimitation, acrylic, acrylonitrile butadiene styrene (ABS), polyamide,polycarbonate, polyester, polyethylene, polypropylene, polystyrene,polyurethane, or combinations thereof. Other materials such as siliconesand rubbers may also be used. When the simulated anatomical component issculpted onto the mounting area, the component may be made from aclay-based or other malleable material. The clay-based material may be apolymer clay (modelling clay), a water-based clay, or an oil-based clay.

In some instances, one or more layers of the cover may include a lip toaid in removably securing the cover to the anatomical model. The lip maybe provided on one or more edges of the cover, and may run continuouslyabout the edge of the cover or discontinuously about the edge (e.g.,there may be intervals or gaps between multiple lips). When disposed ina discontinuous fashion about the edge, any number of lips may beprovided, and they may have any suitable length capable of removablysecuring the cover to the anatomical model. For example, referring toFIG. 9A, an anatomical model (900) includes a cover (902) thereon havinga first edge (904) and a second edge (906). First edge (904) includes afirst lip (908) and second edge (906) includes a second lip (910). Firstand second lips (908, 910) wrap around portions or ends of theanatomical model (900) to secure the cover (902) thereon. To remove thecover (902), first lip (908) may be lifted and peeled off of an end ofthe anatomical model (900), as shown in the direction of the arrow inFIG. 9B. Although the cover in FIGS. 9A and 9B is shown as having lips,other mechanisms for removable attachment of the cover may be used. Forexample, hooks, snaps, or Velcro may be used.

Referring to FIG. 10, when the anatomical model (1000) simulates afemale torso, the cover (1002) may include breasts (1004, 1006). Thecover (1002) may include a lip (1008) such that the cover (1002) may beremoved from the anatomical model (1000) in the direction of the arrow.After a cover is removed, it may be replaced with the same cover or adifferent cover (e.g., a cover including different anatomy). In onevariation, as shown in FIG. 11A, the cover of a female torso (1100) maybe provided with a mounting area (1102) in an unfinished state toresemble a single mastectomy (one breast removed). A simulated breast(1104) may be attached or sculpted onto the mounting area (1102) aspreviously described so that the breasts on the model (1100) aresymmetrical, as shown in FIG. 11B. The creation of symmetry may includesculpting the simulated breast (1104) to have a similar size, shape,and/or position on the anatomical model (1100) as the correspondingbreast on the anatomical model (1100).

As previously stated, the anatomical models may be used as a teachingtool for physicians and surgeons by visually demonstrating a variety ofdifferent conditions and procedures relating to breast augmentation,reconstruction, and/or tissue removal. The models may be useful whenplanning breast surgeries such as tumor removal with local tissuereconstruction, breast reduction, or breast augmentation orreconstruction. For example, the models may help a surgeon visualize andunderstand incision placement and the outcome of using a round vs. othershaped implants in breast augmentation and reconstruction, as well asunderstand how to avoid and revise the most common breast implantmalposition and sizing complications. For example, as shown in FIGS.12A-12D, an anatomical model representative of a female torso (1200) maybe used as a teaching tool to demonstrate and understand incisionplacement (FIGS. 12A and 12D), tissue removal (FIG. 12B), and breastaugmentation (FIG. 12C). Referring to FIG. 12A, various incisions may bedemonstrated in a breast (1202) of female torso model (1200). A lateralincision (1204 a), upper lateral incision (1206 a), and incision aroundthe areola (1208 a) may be made. Closure of those incisions may then beperformed, as indicated by the dotted lines (1204 b, 1206 b, and 1208 b)in FIG. 12D, and assessment performed of how the contour of the breast(1202) is affected by closure of the incisions in those positions. Priorto closure, tissue (1210) may removed from lateral incision (1204 a), asillustrated in FIG. 12C, and a breast implant (1212) inserted into thebreast (1202). The female torso (1200) may be formed to include thevarious tissue layers representative of human anatomy in the area, e.g.,breast tissue, skin, subcutaneous tissue, pectoralis muscle, etc.

Systems

The systems described herein generally include an anatomical model, anadjustable base to which the anatomical model is attached, and one ormore simulated anatomical components for removable attachment to theanatomical model, or one or more materials that may be used to create asimulated anatomical component of the body part, and instructions foruse. One or more covers, as described herein, may also be included. Thecovers may include a mounting area in an altered, unfinished, ordeformed state, which may be configured for completion or reforming byattaching a simulated anatomical component of a body part to themounting area. In some instances, the one or more covers may include aplurality of layers representative of the various tissue layers of ahuman body part or anatomical area, e.g., breast tissue, skin,subcutaneous tissue, pectoralis muscle, etc.

In some variations, the systems for modeling a body part may include anadjustable base and a three-dimensional replica of the body part forcoupling to the adjustable base, where the three-dimensional replica mayinclude a mounting area in an unfinished or deformed area of thethree-dimensional replica. The systems may further include a mechanismfor altering the angle of the adjustable base with respect to a workingsurface, for example, a hinge, ratcheting mechanism, or telescopingtube. The body part may be a female torso and the simulated anatomicalcomponent, a breast. The anatomical models may also include other bodyparts and simulated anatomical components.

In other variations, the system includes one or more simulatedanatomical components for removable attachment to the anatomical model.When a plurality of simulated anatomical components are employed, theymay have different shapes, sizes, volumes, etc. For example, when thesimulated anatomical component is a breast, as shown in FIGS. 1A, 1B,and 2A-2C, the simulated breast may be provided in various shapes,sizes, and volumes.

In variations where one or more materials are packaged in the system andused to create a simulated anatomical component, the simulatedanatomical component may be directly sculpted onto a mounting area ofthe body part, or coupled to the mounting area or body part via a baseplate. When a plurality of materials are included, they may be packagesof the same material or packages of different materials. For example,some packages may include a polymer clay (modelling clay) while othersmay include an oil-based clay. One or more base plates may also beincluded in the systems.

FIGS. 5A and 5B show an exemplary system attached to a tabletop workingsurface. System (500) includes a base comprising a top plate (502) and abottom plate (504), and an anatomical model (506) coupled to the topplate (502) of the base. The bottom plate (504) is secured to theworking surface (508) by tightening knobs (501). The anatomical model(506), which is a three-dimensional replica of a human female torso,includes a mounting area (510) for placement of a simulated breast.Although a female torso and breast are shown in the figures, it isunderstood that other body parts for the anatomical model and othersimulated anatomical components may be used.

The systems may also include a mechanism for adjusting the viewing angleof the anatomical model. For example, a hinge, ratchet assembly, ortelescoping tube and pin arrangement may be used to adjust the anglebetween the top and bottom plates of the base, as previously mentioned.Referring to FIGS. 6A-6F, a telescoping tube arrangement is illustrated.In the figures, anatomical model (600) may be secured to a top plate(602) of a base by screws (604). Screws (604) run through top plate(602) to mate with threaded inserts (606) on the back of anatomicalmodel (600). Although only two screws and threaded inserts can be seen,the system includes four screws and threaded inserts. Any suitablenumber of screws and threaded inserts may be employed. Top plate (602)may be coupled to the bottom plate (608) of the base by a surface mounthinge (610) with or without a spring.

Once the anatomical model (600) is coupled to the top plate (602) of thebase, the height of a telescoping tube (612) attached to the top plate(602) and bottom plate (608) may be adjusted to the thereby adjust theviewing angle of the anatomical model (600). A pin (not shown) may beplaced through holes (614) in the telescoping tube (612) to hold thetube (612) at a certain height, and in turn, stabilize the viewing angleof the anatomical model (600). Referring to FIGS. 6C to 6F, adjustmentof the viewing angle is illustrated by adjusting the height of thetelescoping tube. As shown in the figures, as the height of thetelescoping tube (612) decreases, the angle (A) between the telescopingtube (612) and the bottom plate (608) as well as the working surface(616) decreases, which in turn decreases the viewing angle of theanatomical model (600). The angle (A) between the telescoping tube (612)and bottom plate (608) or working surface (616) may be adjusted fromabout 90 degrees (FIG. 6C), to about 60 degrees (FIG. 6D), to aboutforty-five degrees (FIG. 6E), to zero degrees (FIG. 6F) (so that thetelescoping tube is flat/flush with the bottom plate), or to anysub-angle therebetween. Although a female torso is shown in the figures,it is understood that other body parts for the anatomical model may beused.

In another variation, as illustrated in FIGS. 7A-7D, the viewing anglemay be adjusted using a ratchet assembly (708). In this variation, thebase of the system with an anatomical component removably attachedthereto would first be secured to a working surface. For example, asshown in FIGS. 7A and 7B, the base (700) with an attached anatomicalmodel (702) is secured to a working surface (704) by tightening knobs(706). As shown in FIGS. 7C and 7D, the viewing angle may then beadjusted by moving the ratchet assembly (708) toward the uprightposition such that it pivots from a flat position against the workingsurface (704) to the desired viewing angle. Once at the desired viewingangle, the ratchet assembly (708) locks the position of the anatomicalmodel (702). Although a female torso is shown in the figures, it isunderstood that other body parts for the anatomical model may be used.

Methods

Further described herein are methods related to using the anatomicalmodels for training and patient demonstration. In general, the methodsmay include creating a three-dimensional replica of a body part, wherethe three-dimensional replica includes a mounting area in an unfinishedor deformed portion thereof. The replica may be completed or reformed byattaching a first simulated anatomical component of the body part to themounting area. The simulated anatomical component may be a breast, butother anatomical components may be used. Alternatively, the methods mayinclude securing a cover to the anatomical model that includes amounting area in an unfinished or deformed state, which may be completedor reformed by attaching a simulated anatomical component of the bodypart to the mounting area. The cover may be replaced with a coverrepresenting the same anatomical region or a different anatomicalregion.

In some instances, attachment of the first simulated anatomicalcomponent may be achieved by sculpting the component onto the mountingarea. In one variation, sculpting may comprise creating symmetry betweena first sculpted simulated breast and the corresponding breast on athree-dimensional replica. The creation of symmetry may includesculpting the first simulated breast to have a similar size, shape, orposition on the replica as the corresponding breast on the replica, or acombination thereof.

In other instances, the method may include interchanging the firstsimulated anatomical component with a second simulated anatomicalcomponent having a different size, a different shape, or a combinationthereof. For example, when the system includes a plurality of differentsimulated anatomical components, each may have a different size and/orshape. The different simulated components may be interchanged orswitched with another component to help visually train for recognitionof symmetry, for demonstration, or for surgical planning.

In some variations, the anatomical models may be used during breastsurgery planning. For example, the models may be used during planningfor breast reconstruction, e.g., after mastectomy, breast reduction,breast augmentation, lumpectomy, surgery to correct breast deformity orscarring, etc. In other variations, the anatomical models may be used tovisually train anatomical symmetry. In further variations, theanatomical models may be used for visual training relating to surgicalincision placement, or for visual training relating to breast implantplacement. Additionally, the anatomical models may be used for patientdemonstration, as a tool to illustrate various procedures to achievecertain outcomes.

The training and demonstration models described herein may improve bothpatient and surgical education in plastic surgery, breast surgery, andother surgeries where anatomical symmetry or other aesthetics outcome isdesired. Improved education of healthcare workers including but notlimited to surgeons, nurses and others involved in patient care, may inturn lead to improved surgical outcomes and reduced reoperation rates.The anatomical models may function as a tool that provides patients withan improved educational experience that may help them become betterinformed and therefore better able to make informed consent.

The foregoing description, for purposes of explanation, used specificnomenclature to provide a thorough understanding of the invention.However, it will be apparent to one skilled in the art that specificdetails are not required in order to practice the invention. Thus, theforegoing descriptions of specific embodiments of the invention arepresented for purposes of illustration and description. They are notintended to be exhaustive or to limit the invention to the precise formsdisclosed; obviously, many modifications and variations are possible inview of the above teachings. The embodiments were chosen and describedin order to explain the principles of the invention and its practicalapplications, they thereby enable others skilled in the art to utilizethe invention and various embodiments with various modifications as aresuited to the particular use contemplated.

1. An anatomical model for medical or surgical education and training,surgical planning, or patient demonstration comprising athree-dimensional replica of a body part, the three-dimensional replicacomprising a mounting area in an altered, unfinished, or deformedportion of the replica, wherein the replica is configured for completionby attaching or forming a simulated anatomical component of the bodypart onto the mounting area.
 2. The anatomical model of claim 1, whereinthe body part comprises a female torso.
 3. The anatomical model of claim2, wherein the simulated anatomical component comprises a breast.
 4. Theanatomical model of claim 1, wherein the simulated anatomical componentis configured to be sculpted onto the mounting area.
 5. The anatomicalmodel of claim 1, wherein the simulated anatomical component comprises apolymer clay, a water-based clay, or an oil-based clay.
 6. Theanatomical model of claim 1, wherein the mounting area is configured forremovable attachment of the anatomical component.
 7. The anatomicalmodel of claim 1, wherein the three-dimensional replica comprises aremovably securable cover.
 8. The anatomical model of claim 7, whereinthe removably securable cover comprises a plurality of layersrepresentative of a plurality of tissue layers of the body part.
 9. Theanatomical model of claim 1, wherein the three-dimensional replicacomprises a thermoplastic polymer.
 10. The anatomical model of claim 9,wherein the thermoplastic polymer comprises acrylic, acrylonitrilebutadiene styrene (ABS), polyamide, polycarbonate, polyester,polyethylene, polypropylene, polystyrene, polyurethane, or derivativesor combinations thereof.
 11. An anatomical model for breast surgerytraining, planning, and demonstration comprising a three-dimensionalreplica of a female torso, the three-dimensional replica comprising amounting area in an altered, deformed, or unfinished portion of thefemale torso simulating a post-surgical change of a breast, wherein thereplica is configured for completion by sculpting a simulated breastonto the mounting area or reforming the post-surgical change of thebreast.
 12. A system for modeling a body part comprising: an adjustablebase; a three-dimensional replica of the body part for coupling to theadjustable base, the three-dimensional replica comprising a mountingarea; and one or more materials configured to simulate an anatomicalcomponent of the body part.
 13. The system of claim 12, wherein themounting area is disposed within an altered, unfinished, or deformedarea of the three-dimensional replica.
 14. The system of claim 12,wherein the body part comprises a female torso.
 15. The system of claim14, wherein the simulated anatomical component comprises a breast. 16.The system of claim 12, wherein the three-dimensional replica comprisesa removably securable cover.
 17. The system of claim 16, wherein theremovably securable cover comprises a plurality of layers representativeof a plurality of tissue layers of the body part.
 18. The system ofclaim 12, wherein the one or more materials is configured to be sculptedonto the mounting area.
 19. The system of claim 18, wherein the one ormore materials comprises a polymer clay, a water-based clay, or anoil-based clay.
 20. The system of claim 12, wherein the adjustable basecomprises a ratcheting mechanism for altering the angle of theadjustable base with respect to a working surface.
 21. A methodcomprising: creating a three-dimensional replica of a body part, thethree-dimensional replica comprising a mounting area in an altered,unfinished, or deformed portion of the replica; and completing thereplica by attaching a first simulated anatomical component of the bodypart to the mounting area.
 22. The method of claim 21, wherein attachingcomprises sculpting the first simulated anatomical component onto themounting area.
 23. The method of claim 22, wherein the first sculptedsimulated anatomical component comprises a breast.
 24. The method ofclaim 23, wherein sculpting comprises creating symmetry between thefirst sculpted simulated breast and a corresponding breast on thethree-dimensional replica.
 25. The method of claim 24, wherein creatingsymmetry comprises sculpting the first simulated breast to have asimilar size, shape, or position on the replica as the correspondingbreast on the replica, or a combination thereof.
 26. The method of claim21, wherein the three-dimensional replica comprises a removablysecurable cover.
 27. The method of claim 26, wherein the removablysecurable cover comprises a plurality of layers representative of aplurality of tissue layers of the body part.
 28. The method of claim 27,further comprising placing an implant between two layers of theplurality of layers.
 29. The method of claim 21, further comprisinginterchanging the first simulated anatomical component with a secondsimulated anatomical component having a different size, a differentshape, or a combination thereof.
 30. The method of claim 21, wherein themethod is used for breast surgery planning, visual training ofanatomical symmetry, visual training of surgical incision placement,visual training of breast implant placement, or a combination thereof.